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Hellenic Evaluation of the Long-Term Safety and Efficacy of NalIriFOx as a 1st-line Therapy in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

ConditionMetastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHellenic Cooperative Oncology Group

About this trial

This is multicenter, prospective, open label, non-interventional study that will collect real-world data (RWD) on the clinical efficacy and safety of NalIriFOx as a first-line therapy in metastatic pancreatic ductal adenocarcinoma (mPDAC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with histologically or cytologically proven metastatic PDAC

1st line treatment with NalIriFOx according to physician's choice

Patients willing to provide a Written Informed Consent

Disqualifiers

Patients not matching the above-mentioned inclusion criteria

Neoadjuvant or adjuvant treatment within 6 months from enrolment

Prior treatment with Liposomal irinotecan

Prior treatment of pancreatic cancer in the metastatic setting with chemotherapy or investigational therapy

Trial population

Patients with mPDAC receiving NalIriFOx as first line therapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 1 trial group
Group A: mPDAC patients

Trial outcomes

Primary outcomes

1

Real World Data collection

Record clinical practice and collect real-world data (RWD) on the clinical efficacy and safety of NalIriFOx as a first-line therapy in mPDAC

Time frame
Time from study entry untill completion (12 months)

Secondary outcomes

1

Progression Free Survival (PFS)

PFS of mPDAC patients after first line treatment with NalIriFOx

Time frame
Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 12 months]
2

Overall Survival (OS)

To investigate the long-term prognostic significance of mPDAC patients receiving NalIriFOx as first line therapy, in terms of OS

Time frame
Time from study entry to death from any cause, assessed up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hellenic Cooperative Oncology Group

Lead sponsor

Source ClinicalTrials.gov
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